MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2023

Event Type  malfunction  

Event Description

It was reported to olympus, that the ultrasonic probe had air bubbles at the tip of the device and partially blurry image.Inspection and testing of the returned device found that there was a hole in the sheath at the tip and there was leakage of the ultrasonic medium.There were no reports harm associated with the event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned for evaluation and the customers allegation was confirmed.It was noted that blurred image occurred due to air bubbles at the tip due to occurence of the hole in the sheath.There is a hole in the apical sheath.Additionally, there was leakage of the ultrasonic medium.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause cannot be identified.However, based on the results of the investigation, it is likely that the following led to the malfunction: image is unclear: it is presumed that the ultrasonic image resulted in an event in which the ultrasonic image could not be rendered normally because the ultrasonic medium inside the sheath leaked out due to the occurrence of a hole in the sheath at the tip, and thus the ultrasonic wave could not be transmitted normally.For air bubbles: since a hole is made in the sheath at the tip, air enters into the sheath, so even if air bubbles are removed normally, it is presumed that air bubbles are generated again.About a hole in the sheath at the tip and leakage of ultrasonic media: a perforation has occurred in the apical sheath, indicating that an impact has been applied to the apical sheath.At that time, it is assumed that the ultrasonic medium inside the sheath leaked out because the sheath at the tip was damaged, leading to a hole.This issue is addressed in the instructions for use (ifu): after checking the instructions and product labeling, there were no abnormalities that could lead to the phenomenon.Olympus will continue to monitor the field performance of this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17372470
• MDR Text Key: 320152233
• Report Number: 3002808148-2023-07373
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1